Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study

Recruiting now · Not applicable

Conditions studied: Postpartum Hemorrhage

In brief

The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes. Spinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH. It is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory.

Key facts

Study ID: NCT06285396
Run by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
People needed: 96
Starts: 2024-03-18
Expected to finish: 2026-12-01
Last updated by the study team: 2026-04-06

Who can join

Age: 19 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Patients who have given consent to participate in the study
Patients with gestational age 37-41 weeks
Patients previously diagnosed with either Type II or Gestational diabetes. For the healthy control group, no previous diagnosis is required for inclusion
Patients of 19-45 years
Patients of normal BMI (18-30 BMI) for the healthy control group only
Baby is registered as normal weight for size for the healthy control group only
Non-laboring patients, not exposed to exogenous oxytocin
Patients requiring elective primary or first repeat caesarean delivery
Patients undergoing caesarean delivery under spinal anesthesia

You may not qualify if…

Patients who refuse to give written informed consent
Patients who require general anesthesia
Patients in labor and those receiving oxytocin for induction of labor
Emergency caesarean delivery in labor
Patients who have had previous uterine surgery involving myometrial dissection or >1 previous caesarean delivery
Patients with risk factors for PPH such as those with polyhydramnios, preeclampsia, multiple gestation, morbid obesity, macrosomia (large for size baby), and previous history of PPH. However, for diabetic group, those with morbid obesity and macrosomia will not be excluded as these conditions are almost always associated with diabetes.
For the healthy control group only, a BMI >30 or <18
Maternal age >45

Where it is running

Mount Sinai Hospital — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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